FDA Clears First Soft Robotic Exo-Suit for Stroke Rehab

Megan Brooks

June 07, 2019

The US Food and Drug Administration (FDA) has cleared the ReStore soft exo-suit system, made by ReWalk Robotics, for the rehabilitation of stroke patients who have mobility difficulties, the company has announced.

Stroke affects roughly 17 million people worldwide each year and is a leading cause of disability. As many as 80% of patients experience gait impairments. The ReStore system for stroke rehabilitation is the only soft exo-suit that has been approved by the FDA, the company said. It won CE Mark clearance in Europe last week.

The ReStore system is designed like a soft garment that connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern. The system allows therapists to adjust and optimize treatment using real-time analytics.

The ReStore exo-suit was tested in a multicenter clinical trial in five leading rehabilitation centers in the United States. The data were submitted to the FDA in ReStore's 510(k) submission, and ReWalk expects to publish the results of the clinical study later this year, the company said.

"We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities," Alberto Esquenazi, MD, chief medical officer of Moss Rehab, part of the Einstein Healthcare Network, said in the news release. Esquenazi is an investigator in the trial.

"By training the patient walking pattern in a more correct way, the expectation is that the brain will relearn and better restore the walking function lost after a stroke," said Esquenazi.

The patented soft exo-suit technology was originally developed at Harvard University's Wyss Institute for Biologically Inspired Engineering, where it underwent initial clinical testing that demonstrated its potential to improve walking for stroke patients. ReWalk and the Wyss Institute entered into a research collaboration agreement in 2016.

"The idea of anchoring the body with textiles and flexible soft components is a fundamentally new way of applying assistance with a wearable robot," said Conor Walsh, PhD, professor of engineering and applied sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and faculty member at the Wyss Institute for Biologically Inspired Engineering, Boston, Massachusetts, who led a multidisciplinary team to develop the soft exo-suit technology.

This technology, which has the ability to apply force to the body but not restrict how a person moves, has "broad potential," said Walsh, "and we are currently testing additional concepts which can be applied to provide therapy and/or mobility assistance for individuals with other diseases, such as multiple sclerosis and Parkinson's disease, and also potentially be used by a person at home and in their community."

"With a launch price of $28,900 as well as leasing options, ReStore offers cutting edge innovation with features that redefine therapy at a price that is accessible for a broader range of clinics than existing robotic technologies," ReWalk CEO Larry Jasinski said in a news release. "The current gait training reimbursement codes enable immediate penetration and sales growth as part of our pathway to become a break even and profitable company."

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